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A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique

Primary Purpose

Refractory Overactive Bladder

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ultrasound
X-ray
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Overactive Bladder

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 16 years;
  2. Subjects suitable for SNM surgery;
  3. Normal upper urinary tract function;
  4. Bladder volume > 100 mL;
  5. Good compliance and able to complete the follow-up assessments.

Exclusion Criteria:

  1. Psychiatric or neurologic disabilities on neurologic evaluation such as multiple sclerosis, spinal cord injury, epilepsy, Parkinson's disease, stroke;
  2. Bladder lithiasis or tumor (cystoscopy or ultrasonography);
  3. Stress urinary incontinence;
  4. Bladder outlet obstruction;
  5. Diuresis > 3 liters per 24 hours;
  6. Negative at the test period or previous treatment with SNM;
  7. Pregnancy and plan to be pregnancy in 2 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    US group

    X-ray group

    Arm Description

    lead implantation surgery for SNM using ultrasound guided technique

    lead implantation surgery for SNM using X-ray guided technique

    Outcomes

    Primary Outcome Measures

    Successful rate
    Successful rate is the percentage of patients who experienced a successful result (≥50% improvements in baseline symptoms ) as recorded in voiding dairies.

    Secondary Outcome Measures

    Adverse effect
    Guidance technique performance time
    Times of X-ray radiation
    Overactive bladder symptom score (OABSS)
    Quality of Life (QoL) scores

    Full Information

    First Posted
    October 25, 2016
    Last Updated
    October 25, 2016
    Sponsor
    Beijing Pins Medical Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02946723
    Brief Title
    A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique
    Official Title
    A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB)With X-Ray Guided Technique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    February 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Pins Medical Co., Ltd

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The device include IPG (implantable programme generator) and lead. In the initial test phase, 1st stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This allows your doctors and you to assess your initial response according to your voiding dairy and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG. X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real time visual guidance ,easy to operate by doctors and a radiation free option to challenge anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and dedicating to developing better guidance technique in surgery. The study here compare the efficacy and safety of ultrasound versus X ray guidance technique in SNM.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractory Overactive Bladder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    US group
    Arm Type
    Experimental
    Arm Description
    lead implantation surgery for SNM using ultrasound guided technique
    Arm Title
    X-ray group
    Arm Type
    Sham Comparator
    Arm Description
    lead implantation surgery for SNM using X-ray guided technique
    Intervention Type
    Procedure
    Intervention Name(s)
    ultrasound
    Intervention Description
    Lead implantation surgery for SNM using ultrasound guided technique
    Intervention Type
    Procedure
    Intervention Name(s)
    X-ray
    Intervention Description
    Lead implantation surgery for SNM using X-ray technique
    Primary Outcome Measure Information:
    Title
    Successful rate
    Description
    Successful rate is the percentage of patients who experienced a successful result (≥50% improvements in baseline symptoms ) as recorded in voiding dairies.
    Time Frame
    6 months post -IPG implantation
    Secondary Outcome Measure Information:
    Title
    Adverse effect
    Time Frame
    During operation, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
    Title
    Guidance technique performance time
    Time Frame
    From beginning operation until successful lead placement is completed
    Title
    Times of X-ray radiation
    Time Frame
    During operation
    Title
    Overactive bladder symptom score (OABSS)
    Time Frame
    pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
    Title
    Quality of Life (QoL) scores
    Time Frame
    pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 16 years; Subjects suitable for SNM surgery; Normal upper urinary tract function; Bladder volume > 100 mL; Good compliance and able to complete the follow-up assessments. Exclusion Criteria: Psychiatric or neurologic disabilities on neurologic evaluation such as multiple sclerosis, spinal cord injury, epilepsy, Parkinson's disease, stroke; Bladder lithiasis or tumor (cystoscopy or ultrasonography); Stress urinary incontinence; Bladder outlet obstruction; Diuresis > 3 liters per 24 hours; Negative at the test period or previous treatment with SNM; Pregnancy and plan to be pregnancy in 2 years.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fumin Jia, PhD
    Phone
    010-59361265
    Email
    pins_medical@163.con
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luming Li
    Phone
    010-60736388

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique

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